アジェンダ
8:00 AM — 8:30 AM
8:30 AM — 8:45 AM
10:30 AM — 11:00 AM
11:00 AM — 12:30 PM
Session 2: DEFINITION AND CHARACTERISTICS OF BIOPHARMACEUTICALS12:30 PM — 1:30 PM
1:30 PM — 3:30 PM
Session 3: THE QUALITY REQUIREMENTS FOR BIOPHARMACEUTICALS1:30 PM — 3:30 PM
Session 8: THE CLINICAL DEVELOPMENT OF BIOPHARMACEUTICALS3:30 PM — 4:00 PM
4:00 PM — 5:00 PM
Session 4: GROUP DISCUSSION ON TYPICAL CMC ISSUES5:30 PM — 6:00 PM
6:00 PM — 7:00 PM
8:30 AM — 10:30 AM
Session 6: THE NON-CLINICAL DEVELOPMENT PROGRAMME FOR RECOMBINANT PROTEINS10:30 AM — 11:00 AM
12:30 PM — 1:30 PM
3:30 PM — 4:00 PM
5:00 PM — 6:00 PM
Session 10: THE COMPARABILITY EXERCISE FOR MANUFACTURING PROCESS CHANGES10:30 AM — 11:00 AM
1:00 PM — 2:00 PM
2:00 PM — 2:30 PM
2:30 PM — 3:15 PM
3:15 PM — 3:45 PM
3:45 PM — 5:15 PM
Session 13: OUTLOOK